NCT00000435

Brief Summary

A small protein called dnaJ peptide may help people with rheumatoid arthritis (RA) by preventing their immune system cells from attacking their own tissues. The purpose of this study is to determine if small amounts of dnaJ peptide can "re-educate" immune cells in people with RA so that the cells stop attacking joint tissues.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2000

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

July 31, 2007

Status Verified

July 1, 2007

First QC Date

January 21, 2000

Last Update Submit

July 30, 2007

Conditions

Rheumatoid Arthritis

Keywords

RAImmune ModulationOral TolerancePeptidednaJ

Outcome Measures

Primary Outcomes (1)

  • Area under the curve or 'AUC' obtained by adding 0 for no response and 1 for an ACR 20 response for visits on Day 112, 140, and 168

    time points 112, 140 and 168 of the 6-month trial

Secondary Outcomes (1)

  • Day 112 ACR 20 score

    Visit day 112 of the 6-month trial

Study Arms (2)

A

PLACEBO COMPARATOR

Subjects randomized to arm A received 25mg/day po of placebo

Drug: None-placebo

B

ACTIVE COMPARATOR

Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1

Drug: dnaJ peptide

Interventions

dnaJ peptideDRUG

dnaJP1 was taken in pill form at 25mg/day for 6 months

B
None-placeboDRUG

placebo was taken in pill form at 25mg/day for 6 months

A

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active rheumatoid arthritis as defined by the revised American College of Rheumatology (ACR) 1987 criteria. Evidence of active disease will be based on at least six swollen or nine tender joints.
  • Diagnosis of rheumatoid arthritis of less than 5 years
  • Reactivity to dnaJ
  • Agree to use acceptable methods of contraception
  • Able to understand and sign informed consent

You may not qualify if:

  • Patients taking more 7.5 mg of prednisone or disease modifying agents other than hydrochloroquine or sulfasalazine (i.e., gold, penicillamine, azathioprine, cyclophosphamide, methotrexate, cyclosporine, or anti-TNF agents)
  • Serum creatinine greater than 1.5 mg/dl
  • SGOT less than SGPT
  • Alkaline phosphatase greater than 2 times age/sex adjusted normal values
  • Hematocrit of less than 30
  • Platelets less than 130,000
  • History of lymphoma
  • Any active malignancy or cancer requiring treatment in the last 5 years, except for nonmelanoma skin cancers and carcinoma of the cervix in situ
  • Medical or psychiatric condition or active serious infection
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5093, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Denver Arthritis Center

Denver, Colorado, 80230, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

Virginia Mason Research Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • Prakken BJ, Samodal R, Le TD, Giannoni F, Yung GP, Scavulli J, Amox D, Roord S, de Kleer I, Bonnin D, Lanza P, Berry C, Massa M, Billetta R, Albani S. Epitope-specific immunotherapy induces immune deviation of proinflammatory T cells in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2004 Mar 23;101(12):4228-33. doi: 10.1073/pnas.0400061101. Epub 2004 Mar 15.

    PMID: 15024101BACKGROUND

  • Koffeman EC, Genovese M, Amox D, Keogh E, Santana E, Matteson EL, Kavanaugh A, Molitor JA, Schiff MH, Posever JO, Bathon JM, Kivitz AJ, Samodal R, Belardi F, Dennehey C, van den Broek T, van Wijk F, Zhang X, Zieseniss P, Le T, Prakken BA, Cutter GC, Albani S. Epitope-specific immunotherapy of rheumatoid arthritis: clinical responsiveness occurs with immune deviation and relies on the expression of a cluster of molecules associated with T cell tolerance in a double-blind, placebo-controlled, pilot phase II trial. Arthritis Rheum. 2009 Nov;60(11):3207-16. doi: 10.1002/art.24916.

    PMID: 19877047DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Salvatore Albani, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 21, 2000

First Posted

January 24, 2000

Study Start

September 1, 1999

Study Completion

September 1, 2004

Last Updated

July 31, 2007

Record last verified: 2007-07

Locations

US(8)